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news.Boehringer Ingelheim's Dabigatran etexilate has received 9 to 0 votes from the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee in favour of recommending the drug for stroke prevention in patients with atrial fibrillation (AF).
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Boehringer Ingelheim said that the current recommendations for patients with non-valuvlar atrial fibrillation treated with Warfarin recommend maintaining an international normalised ratio (INR) in the range of 2.0-3.0 through frequent blood monitoring and dose adjustments, which can be challenging for physicians and patients.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said that they were pleased with the committee’s recommendation, which marks an important step in advancing care for patients with atrial fibrillation.
“We believe Dabigatran etexilate will offer patients and doctors the first new treatment option for stroke prevention in atrial fibrillation and we look forward to working with the FDA as it finalises its review of dabigatran,” Dugi said.